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检索条件"机构=Biostatistics and programming"
76 条 记 录,以下是1-10 订阅
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A Seamless Phase II/III Design with Dose Optimization for Oncology Drug Development
arXiv
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arXiv 2024年
作者: Li, Yuhan Zhang, Yiding Mi, Gu Lin, Ji Department of Statistics University of Illinois Urbana-Champaign United States Biostatistics and Programming Sanofi France
The US FDA’s Project Optimus initiative that emphasizes dose optimization prior to marketing approval represents a pivotal shift in oncology drug development. It has a ripple effect for rethinking what changes may be... 详细信息
来源: 评论
Integration of Efficacy Biomarkers Together with Toxicity Endpoints in Immune-Oncology Dose Finding Studies
arXiv
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arXiv 2023年
作者: Zhang, Yiding Xu, Zhixing Quan, Hui Lin, Ji Biostatistics and Programming Sanofi 450 Water Street CambridgeMA02141 United States Biostatistics and Programming Sanofi 55 Corporate Drive BridgewaterNJ08807 United States
The primary objective of phase I oncology studies is to establish the safety profile of a new treatment and determine the maximum tolerated dose (MTD). This is motivated by the development of cytotoxic agents based on... 详细信息
来源: 评论
Dimension reduction with expectation of conditional difference
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Statistical Theory and Related Fields 2023年 第3期7卷 188-201页
作者: Wenhui Sheng Qingcong Yuan Department of Mathematical and Statistical Sciences Marquette UniversityMilwaukeeWIUSA Biostatistics and Programming SanofiUSBridgewaterNJUSA
In this article,we introduce a flexible model-free approach to sufficient dimension reduction analysis using the expectation of conditional difference *** any strict conditions,such as linearity condition or constant ... 详细信息
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A Multi-Arm Two-Stage (MATS) Design for Proof-of-Concept and Dose Optimization in Early-Phase Oncology Trials
arXiv
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arXiv 2023年
作者: Jiang, Zhenghao Mi, Gu Lin, Ji Lorenzato, Christelle Ji, Yuan Department of Statistics University of Chicago 5747 South Ellis Avenue ChicagoIL60637 United States Biostatistics and Programming Sanofi 450 Water Street CambridgeMA02141 United States Biostatistics and Programming Sanofi R&D Vitry-sur-Seine France Department of Public Health Science University of Chicago 5841 South Maryland Avenue ChicagoIL60637 United States
The Project Optimus initiative by the FDA's Oncology Center of Excellence is widely viewed as a groundbreaking effort to change the status quo of conventional dose-finding strategies in oncology. Unlike in other t... 详细信息
来源: 评论
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN HIGH-DIMENSIONAL DATA WITH PPLASSO
arXiv
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arXiv 2022年
作者: Zhu, Wencan Lévy-Leduc, Céline Ternès, Nils UMR MIA-Paris AgroParisTech INRAE Université Paris-Saclay Paris75005 France Biostatistics and Programming department Sanofi R&D Chilly Mazarin 91380 France
In clinical development, identification of prognostic and predictive biomarkers is essential to precision medicine. Prognostic biomarkers can be useful for anticipating the prognosis of individual patients, and predic... 详细信息
来源: 评论
Bayesian methods for the analysis of early-phase oncology basket trials with information borrowing across cancer types
arXiv
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arXiv 2020年
作者: Jin, Jin Riviere, Marie-Karelle Luo, Xiaodong Dong, Yingwen Department of Biostatistics Johns Hopkins Bloomberg School of Public Health BaltimoreMD United States Department of Biostatistics and Programming Research and Development Sanofi Chilly-Mazarin France Department of Biostatistics and Programming Sanofi BridgewaterNJ United States Department of Biostatistics and Programming Oncology Sanofi CambridgeMA United States
Research in oncology has changed the focus from histological properties of tumors in a specific organ to a specific genomic aberration potentially shared by multiple cancer types. This motivates the basket trial, whic... 详细信息
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Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials
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Journal of Biopharmaceutical Statistics 2022年 第6期32卷 954-968页
作者: Hongfei Li Ram Tiwari Qian H. Li a Global Biometrics and Data Sciences Bristol Myers Squibb Princeton New Jersey USAb Department of Statistics University of Connecticut Storrs Connecticut USA a Global Biometrics and Data Sciences Bristol Myers Squibb Princeton New Jersey USA c Department of Biostatistics and Programming Statistics & Data Corporation Tempe Arizona USA
ABSTRACTABSTRACTUtilizing external data from the real world, including data from historical clinical trials, has received increasing interest in drug development. The use of external data to support drug evaluation in... 详细信息
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On multi-armed bandit designs for dose-finding clinical trials
The Journal of Machine Learning Research
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The Journal of Machine Learning Research 2021年 第1期22卷 686-723页
作者: Maryam Aziz Emilie Kaufmann Marie-Karelle Riviere Spotify NYC Univ. Lille CNRS Inria Centrale Lille UMR 9189 CRIStAL Lille France Statistical Methodology Group Biostatistics and Programming department Sanofi R&D Chilly-Mazarin France
We study the problem of finding the optimal dosage in early stage clinical trials through the multiarmed bandit lens. We advocate the use of the Thompson Sampling principle, a flexible algorithm that can accommodate d... 详细信息
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A Classification of Elements of Function Space F(,)
arXiv
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arXiv 2023年
作者: Soltanifar, Mohsen Analytics Division College of Professional Studies Northeastern University 1400-410 West Georgia Street VancouverBCV6B 1Z3 Canada Biostatistics Division Dalla Lana School of Public Health University of Toronto 620-155 College Street TorontoONM5T 3M7 Canada Biostatistics & Programming Division Biometrics Department ClinChoice Inc 750-2 Robert Speck Parkway MississaugaONL4Z 1H8 Canada
In this paper, we classify the function space of all real-valued functions on R denoted as F (, ) into 28 distinct blocks. Each block contains elements that share common features in terms of the cardinality of their s... 详细信息
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GenTwoArmsTrialSize: An R Statistical Software Package to estimate Generalized Two Arms Randomized Clinical Trial Sample Size
arXiv
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arXiv 2024年
作者: Soltanifar, Mohsen Lee, Chel Hee Shirazi, Amin Behnke, Martha Raymond-Loher, Ilfra Dagne, Getachew A. Analytics Division College of Professional Studies Northeastern University 1400-410 West Georgia Street VancouverBCV6B 1Z3 Canada Department of Mathematics and Statistics University of Calgary 2500 University Drive NW CalgaryABT2N 1N4 Canada Department of Statistics College of Liberal Arts and Sciences Iowa State University 2438 Osborn Dr AmesIA50011-1090 United States MPH Biostatistics Program College of Public Health University of South Florida 3010 USF Banyan Circle TampaFL United States Department of Critical Care Medicine Alberta Heath Services University of Calgary 3260 Hospital Dr NW CalgaryABT2N 4Z6 Canada Biostatistics & Programming Division Biometrics Department ClinChoice Inc. 750-2 Robert Speck Parkway MississaugaONL4Z 1H8 Canada Biostatistics & Programming Division Biometrics Department ClinChoice Inc. 11300 Virginia Dr. 4th Floor Fort WashingtonPA19034 United States
The precise calculation of sample sizes is a crucial aspect in the design of clinical trials particularly for pharmaceutical statisticians. While various R statistical software packages have been developed by research... 详细信息
来源: 评论